FDA spokeswoman
Karen Riley was surprised by the news and said that the company has
not yet received approval for the devices and must first get
approved. Approval would involve a lengthy and expensive
process of submitting evidence of the device's efficacy and could
shelve the retail plans for years. However, if the company does
not comply, Riley warns that the FDA may order the devices pulled
from Walgreens' store shelves.

Gene testing has to date
exclusively been conducted in the medical setting. The new
Walgreen test, though, allows buyers to take a saliva sample and then
send it back to the lab for analysis. The company say that the
results can help people make informed medical decisions.

The
kits are set to go on sale at 6,000 of Walgreens' 7,500 stores.
Individual gene tests will retail between $19.99 and $30. Combo
tests are also available such as the drug-response test for $79, the
"pre-pregnancy planning" test for $179, and the health
condition test for $179. All three of the combo tests are
available for $249.

FDA's Riley warns, "The claims have
limitations based on existing science, and consumers should not be
making important medical and lifestyle decisions based on these tests
without first consulting a health-care professional."

Jim
Plante, CEO of Pathway Genomics refutes that his company has done
anything wrong, stating, "There are people who need or want to
know more about their genetic makeup, and we recognize that, for
some, genetic reports are becoming a more important component in
managing their personal health care. The value of knowing how
genes play a role in our personal lives, and potentially the lives of
our children, is critical for making well-informed health and
wellness decisions."

Ed MacBean, vice president of
product development for the company says that his firm will "be
happy to share with the FDA any data that is requested", but
that, "We’re still going to sell the kits at Walgreens because
at this point, we're not aware of any reason we are unable to."

The
FDA according to a
report in The
Sun Times may
also be considering action against online retailers of the test
kits. While Walgreens is the first brick-and-mortar retailer to
offer the kits, they've been available previously online.

“And I don't know why [Apple is] acting like it’s superior. I don't even get it. What are they trying to say?” -- Bill Gates on the Mac ads